Device and method for detecting an actuation action performable with a medical device

ABSTRACT

An apparatus is disclosed, comprising a detector unit comprising a detector configured to detect an actuation action performable via the detector unit to an actuation button of a medical device to cause the medical device to eject at least a portion of a medicament comprised in the medical device. The detector is configured to detect the actuation action based on a detection of a force and/or a touch applied to the detector unit as part of the actuation action. The apparatus further comprises an electric unit connected to the detector and configured to store and/or provide information related to the detected actuation action. Furthermore, an according method and a computer program for controlling this method are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/572,242, filed Sep. 16, 2019, which is a continuation ofU.S. patent application Ser. No. 14/005,877, filed Sep. 18, 2013, nowU.S. Pat. No. 10,446,269, which is a U.S. National Phase Applicationpursuant to 35 U.S.C. § 371 of International Application No.PCT/EP2012/055252, filed Mar. 23, 2012, which claims priority toEuropean Patent Application No. 11159593.0 filed Mar. 24, 2011. Theentire disclosure contents of these applications are herewithincorporated by reference into the present application.

TECHNICAL FIELD

The present invention relates to an apparatus and a method for detectingan actuation action that is performable with a medical device to causethe medical device to eject a medicament that is comprised in themedical device. The invention further relates to a computer program forcontrolling such a method.

BACKGROUND

A variety of diseases exists that require regular treatment by injectionor infusion of a medicament with a medical device that ejects thismedicament. As an example, type-1 and type-2 diabetes can be treated bypatients themselves by injection of insulin doses, for example once orseveral times per day. For instance, a pre-filled disposable insulin pencan be used as an injection device. Alternatively, a re-usable pen maybe used. A re-usable pen allows replacement of an empty medicamentcartridge by a new one. Either pen may come with a set of one-wayneedles that are replaced before each use. The insulin dose to beinjected can then for instance be manually selected at the insulin penby turning a dosage knob and observing the actual dose from a dosewindow or display of the insulin pen. The dose is then injected byinserting the needle into a suited skin portion and pressing anactuation button of the insulin pen.

It is desirable to provide such medical devices for ejection ofmedicaments with functionality beyond their basic medicament ejectioncapabilities, such as for instance functionality to monitor use and/orto prevent false handling (for instance untimely reuse) of the medicaldevices. This requires detection of actuation actions performed with themedical device.

International patent application publication WO 2007/107564 A1 disclosesa method and an electronic module for monitoring the operation of amedication delivery device. An electronic module is releasably arrangedin the vicinity of the medication delivery device and used to detectmeasurable acoustical or vibrational signals generated in response to anaction occurring within the medication delivery device. Informationassociated with or representing the measured signals is then stored.

However, such measurement of acoustical signals (such as for instancesounds generated when dialing or ejecting a dose) may not be reliableenough in noisy environments. The same holds for the detection ofvibrational signals in mobile environments.

SUMMARY

It is thus inter alia an object of the present invention to provide anapparatus and a method for reliable detection of actuation actionsperformed with a medical device. Similarly, a computer programcontrolling such a method is sought.

According to a first aspect of the present invention, an apparatus isdisclosed. The apparatus comprises a detector unit comprising a detectorconfigured to detect an actuation action performable via the detectorunit to an actuation button of a medical device to cause the medicaldevice to eject at least a portion of a medicament comprised in themedical device. Therein, the detector is configured to detect theactuation action based on a detection of a force and/or a touch appliedto the detector unit as part of the actuation action. The apparatusfurther comprises an electric unit connected to the detector andconfigured to store and/or provide information related to the detectedactuation action.

According to a second aspect of the present invention, a method isdisclosed. The method comprises detecting, with a detector, an actuationaction performable via a detector unit that comprises the detector to anactuation button of a medical device to cause the medical device toeject at least a portion of a medicament comprised in the medicaldevice, wherein the detector is configured to detect the actuationaction based on a detection of a force and/or a touch applied to thedetector unit as part of the actuation action. The method furthercomprises storing and/or providing information related to the detectedactuation action.

Also an apparatus configured to perform the method according to thesecond aspect of the present invention shall be considered to bedisclosed.

According to a third aspect of the present invention, furthermore acomputer program is disclosed, comprising instructions operable to causea processor to control the steps of the method according to the secondaspect of the present invention when the computer program is executed onthe processor. The computer program may for instance be storable orencodable in a computer-readable medium. The computer program may forinstance at least partially represent software and/or firmware of theprocessor. The processor may for instance be or be part of the electricunit of the apparatus.

According to a fourth aspect of the present invention, furthermore acomputer-readable medium is disclosed, having a computer programaccording to the third aspect of the present invention stored thereon.The computer-readable medium may for instance be embodied as anelectric, magnetic, electro-magnetic, optic or other storage medium, andmay either be a removable medium or a medium that is fixedly installedin an apparatus or device. Non-limiting examples of such acomputer-readable medium are a Random-Access Memory (RAM) or a Read-OnlyMemory (ROM). The computer-readable medium may for instance be atangible medium, for instance a tangible storage medium. Acomputer-readable medium is understood to be readable by a computer,such as for instance a processor.

In the following, features and embodiments (exhibiting further features)of the present invention will be described, which are understood toequally apply to all aspects of the present invention. These singlefeatures/embodiments are considered to be exemplary and non-limiting,and to be respectively combinable independently from other disclosedfeatures/embodiments with the apparatus, method, computer program andcomputer-readable medium of the present invention as described above.Nevertheless, these features/embodiments shall also be considered to bedisclosed in all possible combinations with each other and with theapparatus, method, computer program and computer-readable medium of thepresent invention as described above.

The medical device is configured to eject a medicament (non-limitingexamples of a medicament, also frequently referred to as a “drug”, are asubstance that, when absorbed into the body of a living organism, altersnormal bodily function; a substance used in the treatment, cure,prevention, or diagnosis of disease or used to otherwise enhancephysical or mental well-being of a creature; or a pharmaceuticalformulation containing at least one pharmaceutically active compound).The ejected drug or medicament may for instance be in a solid (e.g. apowder), liquid or gaseous state, or may comprise a mixture ofcomponents in solid, liquid and/or gaseous states, such as an aerosol.

The ejected medicament may for instance be at least partially (forinstance completely) administered (for instance by way of injection orinfusion) into material, e.g. a body of a creature (for instance a humanbeing or an animal). Non-limiting examples of the medical device arethus an injection device (such as an injection pen) or an infusiondevice (such as an infusion pump). Therein, an injection process may forinstance be differentiated from an infusion process inter alia based onthe time each process takes (For instance, an injection process may havea significantly smaller duration (e.g. less than 5 minutes) as comparedto an infusion process). The administering of the medicament may forinstance be executed with the medical device by an entity (a human beingor a machine). The human being executing the administering of themedicament may then for instance be a patient receiving the medicament,or another person, such as a member of health personnel, such as doctoror a nurse. An example of a medicament to be administered with themedical device is insulin.

The medical device may for instance be a disposable device that isdesigned for a limited number of ejection processes and subsequentdisposal. The medical device may for instance be pre-filled andnon-refillable, so that it has to be disposed after all of orsubstantially all of the medicament(s) contained therein has beeninjected (as a one-way device). Equally well, the medical device may beequipped with exchangeable containers comprising the medicament to beinjected. The medical device may for instance be a pen-shaped injectiondevice with an injection needle at one end and an actuation button atthe other end. The actuation button may for instance protrude from themedical device (for instance at one end thereof) so that it can beactuated by a user by pressing it.

The actuation action causing the medical device to eject at least aportion of the medicament may for instance be applying an actuationforce to the actuation button.

The medical device may for instance be a mechanical device (e.g. apurely mechanical device), which is caused to eject at least a portionof the medicament comprised therein if an actuation force is applied tothe actuation button of the medical device. The actuation force may forinstance be lead to a piston of a medicament container (which maycomprise the medicament directly may comprise a cartridge that containsthe medicament) and may cause a portion of the medicament to be ejectedthrough a needle of the medical device.

Alternatively, the medical device may for instance be an at leastpartially electric medical device, wherein applying an actuation force(which may for instance be smaller than an actuation force applied to amechanical medical device) to the actuation button triggers ejection ofat least a portion of the medicament, for instance by an electric pump.

The actuation action is for instance performed by a human or non-humanuser of the medical device, for instance by a patient that is to receivethe medicament comprised in the medical device, or by medical personnel.The actuation action may for instance by applied by a finger or thumb ofa human user.

According to embodiments of the present invention, the actuation actionis detected by a detector that is comprised in a detector unit. To thisend, the detector unit is arranged with respect to the actuation buttonin a way that the actuation action has to be performed to the actuationbutton at least partially via the detector unit. The detector unit mayfor instance at least partially be placed on top of the actuation buttonor may for instance form an upper part of the actuation button itself.Instead of a surface of the actuation button, then for instance at leasta part of the surface of the detector unit may become the surface wherethe actuation force has to be applied.

The detector unit may for instance be the detector itself. Equally well,the detector unit may comprise further elements. For instance, thedetector unit may be or comprise a housing that at least partiallysurrounds the detector. The detector unit may comprise further parts,for instance parts that relay an actuation force applied via thedetector unit to the actuation button. Parts of the detector unit may becoupled to the detector to allow the detector to detect the actuationaction applied to the actuation button via the detector unit. Thedetector unit may for instance have to be robust enough to relay anactuation force applied via the detector unit to the actuation button.

The detector is configured to detect the actuation action based on adetection of a force and/or a touch applied to the detector unit as partof the actuation action.

As an example, the detector may be an electric switch with an actuator(e.g. a snap element or a pin) that forms part of or protrudes out ofthe detector unit (e.g. a housing or base that supports the detectorfrom below) in a way that the actuator is moved downwards or inwardswhen a force is applied to the actuation button via the detector unit aspart of the actuation action (e.g. an actuation force) and thus closesthe electric switch. The actuator may for instance be covered by amembrane, which is part of the detector unit, to prevent pollution ofthe interior of the detector unit from outside. The electric switch mayfor instance comprise a return element (like for instance a spring) thatcauses the switch to open again once the force is no longer applied.

As another example, the detector may be a piezoelectric sensor that iscomprised in the detector unit (e.g. a housing or a base that supportsthe detector from below) in a way that at least one of its surfacesdirectly or indirectly (e.g. via a membrane of the detector unit)receives the force forming part of the actuation action (e.g. anactuation force) and it thus able to detect it.

As a further example, the detector may be a pressure sensor contained inthe detector unit (which may for instance be a sealed housing) in a waythat a deformation of the detector unit (or movement of parts of thedetector unit) in response to the force forming part of the actuationaction (e.g. an actuation force) causes pressure differences in thedetector unit and thus allows the detector to detect the actuationforce.

As a further example, the detector may be a touch sensor, e.g. anelectric or thermal or optical touch sensor, to name but a few examples.The touch sensor may for instance be the detector unit or may bearranged at a position of the detector unit in a way that it has to betouched when the actuation action shall be performed. For instance, whenthe actuation action is applying an actuation force, the touch sensormay be arranged at a position of the detector unit where the actuationforce is applied.

Detection of the actuation action may for instance be of binary nature,so that it is only detected if an actuation action is performed or not.Therein, an actuation action may for instance only be considered to bepresent if a force component thereof exceeds a pre-defined forcethreshold and/or if a touch component thereof persists longer than apre-defined time duration.

The electric unit is connected to the detector, for instance by a wiredconnection, and configured to store and/or provide information relatedto the detected actuation action. Therein, the information may forinstance be provided to a user of the medical device, for instancevisually, acoustically, haptically or by means of vibration, and/or maybe provided to an electronic device, such as for instance a mobile phoneor a computer.

The electric unit may for instance be an electric circuit. In acomparably simple embodiment, the electric circuit implements a timerthat is activated when an actuation action is detected and then causesand/or generates an indication on the detected actuation action (e.g.causes an LED to be turn on) for a pre-determined duration of time.After the time, the indication stops (e.g. the LED is turned of). Inmore complex embodiments, the electric unit may comprise a processor andoptionally further functional units, like for instance a wirelesstransmission module or a display module.

According to embodiments of the present invention, thus instead of anacoustic or vibrational detection of actions performed with the medicaldevice, a detection of actuation actions based on a force and/or a touchapplied to the actuation button of the device via the detector unit isperformed, which is generally much more robust. Since the force and/orthe touch have to be performed by a user of the medical device as partof the actuation action anyway, no additional handling steps arerequired. Information on the detected actuation action is then forinstance provided to a user of the medical device and/or to anotherentity to inform the user and/or the other entity on the actuationaction. In this way, for instance a current status and/or a history ofan application procedure performed with the medical device can beindicated. This supports a user and/or the other entity with respect tohandling of the medical device and contributes to product safety.

According to an embodiment of the invention, the force acts on thedetector directly or via at least a part of the detector unit, or isdetected by the detector because the detector is responsive to amovement and/or a deformation of at least a part of the detector unitcaused by the force.

The force may for instance act directly on an actuator (e.g. a snapelement or pin) of an electric switch that forms part of or protrudesout of the detector unit, or may directly act on a piezoelectric sensor.Equally well, the force may act on an electric switch or a piezoelectricsensor via a membrane of the detector unit. The force may equally wellbe relayed to the sensor (e.g. an electric or optical switch or apiezoelectric sensor) via parts or components of the detector unit thatare movably mounted in the detector unit. The force may also be detectedbased on a deformation of the detector unit, which may cause a change inthe pressure of the (sealed) detector unit that is detectable by apressure sensor within or coupled to the detector unit.

According to an embodiment of the apparatus according to the firstaspect of the invention, the apparatus comprises an attachment unit forfixedly or releasably attaching the apparatus to the medical device.

The apparatus may for instance be considered to be fixedly attached tothe medical device if it can only be removed from the medical deviceunder destruction of at least a part of the medical device and/or of atleast a part of the apparatus. The apparatus may for instance beconsidered to be releasably attached to the medical device if it can beremoved from the medical device without destruction of the medicaldevice and the apparatus, for instance in a way that the apparatus cansubsequently be attached to the medical device or another medical deviceagain. Non-limiting examples of an attachment unit are components thatallow for a form closure, fit closure, screw coupling or Velcro-likecoupling between the apparatus and the medical device. For instance, theattachment unit may be configured to engage with or at least partiallyembrace the medical device, for instance with one or more arms, clips orrings.

The apparatus thus may for instance be a module that is attached to themedical device after manufacturing of the medical device is completed(or for instance as the last production step). The apparatus may forinstance be attached to the medical device by a user of the medicaldevice. The apparatus may for instance comprise pre-stored informationon the medical device to which it can be attached (like for instance thetype of medicament contained therein, and/or the amount of medicamentcontained therein). The apparatus may for instance be designed in such away that it can only be attached to specific medical devices, and thatattachment to other medical devices (for instance with medical devicesthat contain another medicaments) is not possible. This may for instancebe achieved by different designs of the attachment unit and/or of theportions of the medical devices to which the apparatus can be attachedto. For instance, apparatuses for different medical devices may beprovided with different protrusions in their attachment units thatcooperate with grooves on the portions of the medical devices to whichthe apparatuses shall be attached. Attachment of an apparatus may thenonly be possible if the protrusion of the apparatus matches the grooveon the medical device.

The attachment unit may for instance be adapted to fit on an outercircumference of at least a portion of the medical device, for instanceby form closure, fit closure, or screw coupling. The portion of themedical device may for instance be at least a portion of the actuationbutton, for instance an upper end thereof, or at least a portion of adosage selector (such as for instance a ring-shaped dosage knob that isrotated around a longitudinal axis of the medical device to select adose), or at least a portion of a housing of the medical device (forinstance a part of the housing below a dose selector of a medicaldevice).

A housing of the detector unit may for instance be coupled to orintegrally formed with the attachment unit. For instance, the housingmay have a cylindrical or conical form, wherein a lower part of thehousing forms the attachment unit, for instance with an opening at thelower end to be placed on top of the actuation button, and an upper partof the housing forms at least a part of the detector unit. The detectormay then be arranged within an opening at the upper end of the housing,for instance in a way that it is at least partially covered by thehousing or by a membrane attached to the housing.

According to an embodiment of the invention, the detector is one of anelectric switch, a piezoelectric sensor, an optical sensor, a pressuresensor and a touch sensor.

According to an embodiment of the invention, the information related tothe detected actuation action is information related to an instant oftime at which the actuation action is detected. The instant of time mayfor instance be displayed, for instance via a display element of theapparatus, to indicate to a user when the medical device was used thelast time, and thus to prevent to early re-use of the medical device,for instance in case that a user forgot that he already used the medicaldevice.

According to an embodiment of the invention, the information related tothe detected actuation action is a representation of a time instant atwhich the actuation action is detected, or a representation of a timeduration that has passed since the actuation action was detected, or aninformation that a pre-defined time duration since the actuation actionwas detected has already passed or not.

According to an embodiment of the apparatus according to the firstaspect of the invention, the electric unit is configured to determine alength of a time interval during which the actuation action is applied,and to store and/or provide information related to the determined lengthof the time interval and/or to store and/or provide the informationrelated to the detected actuation action in dependence on the determinedlength of the time interval. The length of the time interval may forinstance be indicative of the type of action that was performed with themedical device. For instance, a time interval with a length above apre-defined threshold (for instance 2 or 5 seconds) may indicate thatthe medical device was used for an injection/infusion, whereas a timeinterval with a length below the pre-defined threshold may indicate thata priming operation was performed with the medical device. In the lattercase, for instance no information on the detected actuation action maybe stored and/or provided. A priming (or commissioning) of the medicaldevice may for instance be performed when using the medical device forthe first time or after a change of a medicament container. In thepriming operation, only a comparably small number of units of themedicament is ejected.

According to an embodiment of the apparatus according to the firstaspect of the invention, the electric unit further comprises a provisionunit configured to provide information on the information related to thedetected actuation action optically, acoustically, haptically, byvibration, or by transmission to an electronic device that is differentfrom the medical device. The information may for instance be displayedvia a display or via one or more light sources, such as for instanceLight Emitting Diodes (LEDs). Therein, for instance different coloursmay convey different information. As an example, if a time durationsince a last detected actuation action is below a pre-defined threshold,a red light may be shown, whereas if the time duration since the lastdetected actuation action is above the pre-defined threshold, a greenlight may be shown. The red light then may indicate that the medicaldevice should not be used, whereas the green light indicates that themedical device can be used again. This may for instance prevent tooearly re-use of the medical device, for instance in cases where a userforgot that he/she already used the medical device shortly before.

Equally well, the information on the information related to the detectedactuation action may be transmitted to the electronic device, forinstance by wireless (e.g. optical or radio transmission, such as forinstance a Bluetooth transmission) or wirebound transmission. In thelatter case, the electric unit of the apparatus may for instancecomprise an interface for a cable to be connected, such as for instancea Universal Serial Bus (USB) interface. The electronic device may forinstance be a mobile phone or a computer, where for instance a log onthe actions performed with the medical device may be kept.

Therein, the electronic device may for instance be configured to storethe information, for instance in the form of a logbook or archive,and/or to use the information to monitor use of the medical device (forinstance to launch an alert if improper handling of the medical deviceis detected), and/or to use the information (and potentially furtherinformation) to determine a proposal of the next type and/or dose ofmedicament to be administered, optionally with a proposal for the timeinstant when the dose should be applied. In an example embodiment, suchinformation may be provided back to the apparatus and may optionally bedisplayed to a user of the apparatus.

The electronic device may for instance be or at least implement (forinstance via an application (such as a mobile phone applicationavailable on or via the internet) that can be installed to theelectronic device to enhance its functionality) a blood glucosemonitoring system, which may for instance reveal individual patterns ofblood glucose changes and may help in the planning of meals, activities,and at what time of day to take medicaments or to administer amedicament.

The blood glucose monitoring system may for instance comprise a bloodglucose meter for measuring the blood glucose level of the patient thatuses the medical device, or may (for instance regularly or irregularly)receive information on this blood glucose level from a blood glucosemeter. The blood glucose meter may for instance measure the bloodglucose level based on a drop of blood placed on a disposable test stripwhich interfaces with a digital meter.

Provision of the information on the information related to the detectedactuation action may be triggered by a user (e.g. by pushing a button ofthe apparatus) or automatically, for instance in response to a detectionof an actuation action, or on a regular or irregular basis that can bedefined by a user of the apparatus.

In addition to the information on the information related to thedetected actuation action, further information may be provided by theapparatus (or its provision unit). Non-limiting examples of suchinformation is information related to the type and/or original orcurrent amount of medicament contained in the medical device, anexpiration date of the medicament contained in the medical device, atime instant of a first actuation action detected (or a time durationsince this first detected actuation action) for the medical device(potentially after a resetting operation performed with the electricunit), and a time instant since a resetting operation performed with theelectric unit. At least a part of this information may for instance bepre-stored in the apparatus, and/or may be programmed into the apparatusby a user via a wireless or wirebound interface or via a user-interfaceof the apparatus (which, in the simplest case, may for instance only bea button).

According to an embodiment of the apparatus according to the firstaspect of the invention, the apparatus further comprises a dosedetermination unit configured to determine a dose of the medicamentselected before the actuation action is applied, wherein the dosedetermination unit is connected to the electric unit and wherein theelectric unit is further configured to store and/or provide informationrelated to the determined dose and/or to store and/or provide theinformation related to the detected actuation action in dependence onthe determined dose. For instance, if the determined dose is below apre-determined threshold, the actuation action may be classified as apriming action only, and no information on the detected actuation actionand/or the determined dose may be stored and/or provided.

The dose determination unit may for instance be configured to determinethe dose by sensing sounds that occur when a dose selector of themedical device is operated (for instance sounds caused by mechanicalelements of the medical device moving with respect to each other duringdose selection), or by sensing a movement of the dose selector. Themovement may comprise a rotational movement, a linear movement, or acombination of a rotational and a linear movement, for example a helicalmovement, and/or the like. In case of an injection pen, the movement maybe a rotational or a helical movement. The rotational component of themovement may for instance be determined optically based on a ratchetdisk that is affixed to the dose selector and a cooperating lightbarrier, or by a toothed disk affixed to the dose selector and acooperating electric switch.

According to an embodiment of the apparatus according to the firstaspect of the invention, the electric unit is further configured toprovide information allowing for identifying, locating or finding themedical device. The information may for instance be provided in responseto a reception of a triggering signal (for instance a radio signal or anacoustic signal like a whistle), or under the control of the electricunit, for instance periodically.

These and further concepts of the invention will be apparent from andelucidated with reference to the detailed description presentedhereinafter.

BRIEF DESCRIPTION OF THE FIGURES

In the figures show:

FIG. 1 is an exploded view of an injection device and an embodiment ofan apparatus according to the present invention;

FIG. 2 shows a cross-sectional view of an embodiment of an apparatusaccording to the present invention;

FIG. 3 shows an embodiment of a circuit diagram of an electric unit ofan apparatus according to the present invention; and

FIG. 4 shows a flowchart of an embodiment of a method according to thepresent invention.

DETAILED DESCRIPTION

Embodiments of the present invention inter alia address the need forenhancement of purely mechanical one-way or multi-way/re-usableinjection/infusion products, such as insulin injection pens), which donot provide a power supply, with additional functions, such as forinstance a usability indication, an alarm function or patient-specifictherapy functions.

Since native integration of such additional functions intoinjection/infusion products increases their costs, it is generallydesirable to provide such functions based on an additional add-onmodule.

Due to the complexity and criticality of infusion/injection devices, itis advantageous that such an add-on module is provided without requiringconstructional changes of the infusion/injection devices to which itshall be added.

Furthermore, it is advantageous (e.g. cost-efficient) that the add-onmodule can be easily and quickly attached to the infusion/injectiondevices with only minor change of production lines for theinfusion/injection devices (in case that the add-on module is attachedto the infusion/injection devices as the last or one of the lastproduction steps) or by hand assembly (for instance by a user of theinfusion/injection device itself), even in case of low quantities.

Embodiments of the present invention allow for easy and cost-efficientaddition of functions (for instance supported by a power source such asfor instance a battery) to medical devices. These functions may forinstance comprise one or more of:

-   -   indicating the time since the last application or until the next        application (for instance optically or acoustically),    -   reminding of a time (for instance optically, acoustically or by        means of vibration),    -   indicating usability (for instance optically, acoustically or by        means of vibration), and/or    -   allowing identification (for instance via Radio Frequency        Identification, RFID).

Modules/apparatuses according to embodiments of the present inventionmay for instance be attached to the medical devices in one or more ofthe following forms:

-   -   The attachment may be persistent (fixedly, i.e. non-releasably),        for instance as an additional production step during        manufacturing of the medical device and/or the module. For        instance, the module may be clicked on a dosage knob or        actuation button of a medical device, or may be attached to the        medical device via a snap/latch mechanism, allowing for        cost-efficient automatic assembly or assembly by hand.    -   The attachment may be persistent (fixedly) for each medical        device, but may be accomplished by the user of the medical        device.    -   The attachment is releasably (e.g. only temporary). The module        may then for instance be transferrable from medical device to        medical device and thus be reusable, yielding cost savings for        the user.

Modules/apparatuses according to embodiments of the present inventionmay for instance comprise one or more of the following components:

-   -   a power unit,    -   a housing with a (standardized) attachment unit for attachment        to a medical device,    -   a functional unit, optionally with an integrated switch or        sensor,    -   optionally an indicator/actuator/signal generator,    -   optionally a transmitter,    -   optionally a receiver.

The functional unit may be flexible in its functionality and may forinstance comprise one or more of the following:

-   -   a timer, optionally with a programming interface,    -   an indicator function for allowing the medical device to be        found/located (for instance like a key finder), optionally in        combination with an external transmitter or an external        activation    -   an RFID unit and/or a storage medium.

Examples of the indicator/actuator/signal generator may for instancefunction in one or more of the following ways:

-   -   optically, for instance via an LED,    -   acoustically (for instance speech generation or sound signal),    -   by means of oscillation, for instance by vibration,    -   via a data set, for instance comprising one or more of an        expiration date, a production date, an indication of the type of        medicament, an active ingredient of the medicament, a serial        number.

In the following, an embodiment of the present invention will bedescribed with reference to an insulin injection device, to which amodule (as an embodiment of an apparatus according to the presentinvention) is attachable or attached. The present invention is howevernot limited to such application and may equally well be deployed withinjection/infusion devices that eject other medicaments, or with othertypes of medical devices.

FIG. 1 is an exploded view of an injection device 1 and a module 2.Injection pen 1 may for instance represent Applicant's ClikSTAR® insulininjection pen.

Injection device 1 of FIG. 1 is a reusable injection pen that comprisesa housing 10 and contains an insulin container 14, to which a needle 15can be affixed. Insulin container 14 contains a cartridge (not detailedin FIG. 1 ) that actually contains the insulin and can be replaced witha new cartridge when empty, making injection device 1 reusable. Theneedle 15 is protected by an inner needle cap 16 and an outer needle cap17, which in turn can be covered by a cap 18.

An insulin dose to be ejected from injection device 1 can be selected byturning the dosage knob (dosage selector) 12, and the selected dose isthen displayed via dosage window 13, for instance in multiples ofso-called International Units (IU), wherein one IU is the biologicalequivalent of about 45.5 μg pure crystalline insulin ( 1/22 mg). Anexample of a selected dose displayed in dosage window 13 may forinstance be 30 IUs, as shown in FIG. 1 .

Turning the dosage knob 12 may cause a mechanical click sound to provideacoustical feedback to a user. The numbers displayed in dosage window 13are printed on a sleeve that is contained in housing 10 and mechanicallyinteracts with a piston in insulin container 14 (and the cartridgecontained therein). When needle 15 is stuck into a skin portion of apatient, and then actuation button (injection button) 11 is pushedinwards, for instance by a thumb of the user of injection device, theinsulin dose displayed in display window 13 will be ejected frominjection device 1. When the needle 15 of injection device 1 remains fora certain time in the skin portion after the injection button 11 ispushed, a high percentage (or even all) of the dose is actually injectedinto the patient's body.

Injection device 1 may be used for several injection processes. Asstated above, an empty insulin cartridge (positioned in insulincontainer 14) can be replaced by a new one.

Before using injection device 1 for the first time (or after a change ofthe cartridge), it may be necessary to perform a so-called “prime shot”to remove air from the cartridge in insulin container 14 and needle 15,for instance by selecting two units of insulin and pressing actuationbutton 11 while holding injection device 1 with the needle 15 upwards.

In FIG. 1 , further a module 2 is shown, which is attachable toactuation button 11 of injection device 1, for instance by clicking orpressing it onto actuation button 11, for instance to achieve a formclosure or fit closure. Equally well, module 2 may be screwed onactuation button 11, or may be glued thereon.

This may for instance be performed by a user of injection device 1, andmay lead to either a fixed or releasable connection between module 2 andinjection device 1. As already described above, module 2 may equallywell be attached (either fixedly or releasably) to injection device 1during production of injection device 1. Module 2 comprises a detectorunit with a detector that detects an actuation action performed toactuation button 11, and an electric unit for storing or providinginformation related to this detected actuation action.

Mounting module 2 on actuation button 11 has the advantage that module 2can be affixed without requiring modification of the injection device 1,and that a robust detection of actuation actions can be achieved, sinceactuation actions can only be applied to actuation button 11 via module2.

FIG. 2 is a cross-sectional view through the centre of an embodiment ofthe module 2 of FIG. 1 when it is attached to actuation button 11 ofinjection device 1.

Module 2 comprises a housing 20, which is of cylindrical shape with acircular inner protrusion 200. Housing 20 may for instance be made ofaluminium.

Above the circular protrusion 200 of housing 20, an electric circuit 22is positioned. Electric circuit 22 may be attached to housing 20, forinstance by gluing, but equally well, no specific attachment may beperformed, for instance to allow electric circuit 22 to be removed frommodule 2, for instance to change electric circuit 22. Electric circuit22 is for instance formed on a printed circuit board, which may have oneor more layers of wiring. On top of electric circuit 22, a lightemitting diode (LED) 220 is positioned, which is under control of theelectric circuit 22.

Electric circuit 22 is connected to the poles of a battery 23 (e.g. acoin cell), which is positioned below electric circuit 22 and at leastpartially within circular protrusion 200, via contacts (for instance oneor more contacts that contact battery 23 laterally (first pole) and oneor more contacts that contact battery 23 at its top (second pole)) notshown in FIG. 2 . Electric circuit 22 is thus powered by battery 23.Battery 23 may for instance be held in circular protrusion 200 (forinstance a battery holder with included contacts, which may for instancebe attached to or formed on the bottom of electric circuit 22) and maybe removed, for instance for replacement, by pulling it downwards out ofcircular protrusion 200.

On top of electric circuit 22, contact areas 211 are formed, which areconnected to electric circuit 22 as will be discussed with reference toFIG. 3 below. Module 2 further comprises a snap disk 210, which has anelectrically conductive portion 2100 on its lower side and is arrangedwith respect to contact areas 211 in way that if a downward force isapplied to snap disk 210, snap disk 210 deforms and electricallyconductive portion 2100 of snap disk 210 comes into contact with contactareas 211, so that these contact areas 211 are electrically connected.Snap disk 210 and contact areas 211 thus form an electric switch 21,which functions as a detector for a force applied to snap disk 210. Areset force for this electric switch 21 is provided by snap disk 210 ina way that, if the downward force is no longer applied to snap disk 210,snap disk 210 returns into its previous position. Snap disk 210 isdesigned to be at least partially transparent, so that light emitted byLED 220 can be perceived through snap disk 210. To this end, snap disk210 may for instance have circular or ring-shaped transparent areas. InFIG. 2 , such a circular transparent area 2101 is indicated in snap disk210.

Below the circular protrusion 200 of housing 20, module 2 forms acircular space for absorption of at least a part of actuation button 11of injection device 1. This space may at least partially also be used bya lower portion of battery 23. The radius of this circular space isadapted to the outer radius of actuation button 11 in a way that module2 can be attached to actuation button 11 and firmly rests on actuationbutton 11, while still being releasable from actuation button 11 withoutdestroying module 2 and actuation button 11, for instance if injectiondevice 1 is replaced by another injection device, but module 2 shall bereused.

Example measures for the module 2 of FIG. 2 are a total height of 10.67mm, with the height of the housing above the circular protrusion being 3mm, and the height of the housing below the circular protrusion being5.4 mm. The total diameter of module 2 may for instance be 17 mm, andthe inner diameter of circular protrusion 200 may for instance be 11 mm.

Functionally, electric switch 21, electric circuit 22, battery 23 andthe upper part of the housing 20 with circular protrusion 200 form adetector unit. An actuation action (which in the present embodimentcorresponds to an actuation force) can be exerted to actuation button 11of injection device 1 only via this detector unit and is detected byswitch 21 that functions as a detector. In case that battery 23 is notin contact with actuation button 11 (unlike the example shown in FIG. 2), the detector unit may be considered to only comprise electric switch21, electric circuit 22 and the upper part of housing 20 with circularprotrusion 200, since these components relay the actuation force toactuation button 11.

Switch 21 is configured to detect the actuation action based on adetection of a force applied to the detector unit as part of theactuation action. In particular, when desiring to cause ejection of aselected dose of the medicament contained in injection device 1, theactuation force is initially applied to snap disk 210, which is thenpushed downward to come into contact with contact areas 211. Theactuation force is then relayed to circular protrusion 200 via theelectric circuit 22 and battery 23, and then relayed to its actualdestination, the actuation button 11, via the circular protrusion 200.

It is readily clear for a person skilled in the art that a plurality ofalternatives exists for the arrangement of components shown in FIG. 2 .For instance, to avoid that the actuation force has to be applied toactuation button 11 inter alia via the electric circuit 22 (and, asshown in FIG. 2 , battery 23), which may cause damages to thesecomponents, contact areas 211 may for instance not be formed on top ofelectric circuit 22, but on a separate carrier plate, to which also thesnap disk 210 is connected. This carrier plate may then for instanceonly be in contact with the electric circuit 22 at an outer regionthereof (i.e. near housing 20), so that an actuation force applied tothis carrier plate may then be relayed only to the outer region ofelectric circuit 22 and thus may avoid damage of components in the innerregion of electric circuit 22.

Equally well, of course other types of electric switches may be used.For instance, instead of snap disk 210, a rigid plate or cap (e.g.convex or concave) may be used attached on top of housing 20 and with acentral opening through which an actuator of an electric switch (e.g. akey switch) protrudes, wherein the length of the way the actuator has tobe moved down to close the electric switch is chosen so that the switchis closed when the top of the actuator and the top surface of the plateare aligned, and that in this position and also when applying furtherforce on the plate, only the reset force of the switch (for instancecause by a reset spring) acts on components to which the switch ismounted. When applying an actuation force via this plate, then theactuator of the electric switch is pressed inwards and the electricswitch is closed. Further applying the actuation force then leads to theactuation force being relayed to the actuation button 11 via the housing20 and its protrusion 200, and not via the electric circuit 22 and thebattery 23.

Equally well, of course other types of detectors may be deployed, suchas for instance a touch sensor arranged on, in or below a plate (or cap)placed on top of housing 20, or a pressure sensor that is arrangedwithin housing 20 and is responsive to changes in pressure caused withan upper part of housing 20 when a force is applied to a flexiblemembrane or other moving member attached to the top of housing 20(assuming that housing 20 is otherwise tight, which may for instance beachieved by replacing protrusion 200 by a solid plate).

In the module 2 of FIG. 2 , the electric circuit 22 is connected toswitch 21, in particular to its contact areas 211, and providesinformation related to the actuation action detected when switch 21 isclosed. In the embodiment of FIG. 2 , electric circuit 22 implements atimer that is activated when switch 21 is closed and turns on LED 220for a pre-defined time. Lighting of the LED 220 thus indicates to a userof injection device 1 that a pre-defined time period since a lastactuation action has not yet passed, and thus may for instance preventtoo early reuse of the injection device 1, for instance in case that theuser forgot that he already used the injection device 1 shortly before.

FIG. 3 shows an example of a circuit diagram 300 for the electriccircuit 22 of module 2 of FIG. 2 .

The electric circuit implements a monostable multivibrator with a timerelement U1 (such as for instance Texas Instruments' TLC555, which is alow-power variant of an NE555 timer) at its core. X1 and X2 denotebattery contacts connected to one pole of battery 23 (supply voltagepotential Vcc). These two contacts may for instance contact battery 23laterally. X3 is a battery contact connected to the other pole ofbattery 23 (ground potential GND), which may for instance be arranged atthe top of battery 23. Battery 23 may for instance be a coin cellbattery, such as for instance of type CR1025.

In circuit diagram 300, S1 represents electric switch 21 of FIG. 2 , andV1 denotes LED 220 of FIG. 2 . Furthermore, R1, R2, R3 and R4 areresistors, and C1, C2 and C3 are capacitors.

The electric circuit of FIG. 3 functions as follows: If switch S1 isclosed, LED V1 is turned on and emits light. After a pre-defined time,which is governed by the values of R3 and C3 (T=R*C), LED V1 is turnedoff again.

For instance, the pre-defined time may be set to 15 minutes. LED V1 thenis active for 15 minutes after the last use of the injection device 1and in this way reminds a user that injection device 1 has already beenused.

As already stated above, indication that a pre-defined time durationsince the last actuation action has not yet passed is only one exampleof additional functionality that can be added to an injection deviceaccording to embodiments of the present invention. Equally well, module2 may be modified to convey other information. For instance, the timeinstant of the last detected actuation action (or a history of the lastdetected actuation actions) may be indicated to a user, for instanceoptically (via a display integrated into module 2) or acoustically (forinstance via speech generation or via sounds). This indication may forinstance be performed in response to a request of the user, which mayfor instance be made by the user by pressing a button. Equally well,information on detected actuation actions (e.g. the last detectedactuation action, or a history of the last detected actuation actions)may be stored in a memory of module 2, and/or may be provided toelectronic devices via wired or wireless connections. The module 2 mayalso be equipped with a key finder functionality.

Electric circuit 23 of module 2 may also comprise a processor (such asfor instance a microprocessor) that controls functions of module 2. Thisprocessor may for instance store and/or provide information related toan actuation action detected by a detector, such as for instance anelectric switch (e.g. switch 21) or any other type of detector.

FIG. 4 is a flowchart 400 of an embodiment of a method according to thepresent invention. This method may for instance be at least partiallycontrolled and/or performed by a processor of module 2. A computerprogram with instructions operable to cause the processor to performthis may be stored on a computer-readable medium, which may for instancebe a tangible storage medium. In a step 401, an actuation action isdetected, and in a step 402, information related to the detectedactuation action is stored and/or provided.

Module 2 of FIG. 2 may furthermore be equipped with a further componentthat is capable of measuring a dose that is dialed with dosage knob 12(see FIG. 1 ). This component may for instance be formed on or attachedto a lower portion of module 2 and may comprise a rotatable member thatis attached to dosage knob 12 so that rotation thereof with respect tomodule 2 can be sensed. Information on this sensed rotation may then betransformed by the electric circuit 22 (or a processor of module 2) intoinformation on a selected dose and may be stored and/or provided likethe information on a detected actuation action. Alternatively, anacoustic sensor may be used in module 2 to determine a selected dosebased on click sounds produced by injection device 1 when a dose isdialed.

The rotation may be measured relative to another part of the knob 12 orrelative to a part of the injection device 1, for example relative tothe housing 10, or relative to the dose dial sleeve that can be seenthrough the dosage window 13. By measuring the relative movement, it canbe distinguished whether the dialed dose is measured or whether theinjected dose is measured. In an example embodiment, dosage knob 12 maybe rotated during dose dialing relative to housing 10, however it maynot rotate relative to the housing 10 during dose injection. Thus, adialed dose can be measured.

In an example embodiment, dosage knob 12 may be rotated during dosedialing relative to housing 10, but no rotational movement is maderelative to the dose dial sleeve. During dose injection, the dose dialsleeve rotates. Thus, a relative rotational movement between the dosedial sleeve and the dosage knob may be detected during dose injection.As the module 2 is fixed to the dosage know 12, it may detect therelative movement.

The invention has been described above by means of embodiments, whichshall be understood to be non-limiting examples only. In particular, itshould be noted that there are alternative ways and variations which areobvious to a skilled person in the art and can be implemented withoutdeviating from the scope and spirit of the appended claims.

The invention claimed is:
 1. A medical device comprising: a modulecomprising: a switch configured to detect an actuation action of amedical device, the actuation action causing the medical device to ejectat least a portion of a medicament in the medical device, and anelectric unit connected to the switch and configured to store and/orprovide information related to the detected actuation action; a housing;a dosage knob configured for rotation relative to the housing duringdose dialing and configured not to rotate relative to the housing duringdose injection; and a dose dial sleeve, wherein the medical device is aninjection device, wherein the module is attached to the dosage knob,wherein during the dose dialing, the dosage knob and the dose dialsleeve are stationary relative to one another, and during the doseinjection, the dose dial sleeve rotates relative to the dosage knob, andwherein a relative rotational movement between the dose dial sleeve andthe dosage knob is detected by the module during the dose injection. 2.The medical device according to claim 1, wherein the dosage knob isconfigured to be rotated around a longitudinal axis of the medicaldevice to select a dose of the medicament.
 3. The medical deviceaccording to claim 2, wherein the module comprises a rotatable memberthat is configured for attachment to the dosage knob.
 4. The medicaldevice according to claim 1, comprising a medicament containerconfigured to contain a cartridge of the medicament.
 5. The medicaldevice according to claim 1, wherein the dosage knob is configured to beturned to select a dose of the medicament to be ejected by the medicaldevice.
 6. A medical device comprising a housing; a container configuredto contain a cartridge of a medicament; a dosage selector configured tobe rotated around a longitudinal axis of the medical device to select adose of the medicament; a dose dial sleeve configured to rotate duringdose injection; and a module comprising a detector to detect arotational movement of the dose dial sleeve relative to the dosageselector during the dose injection, the module comprising a switchconfigured to detect an actuation action of a medical device, theactuation action causing the medical device to eject at least a portionof the medicament in the cartridge.
 7. The medical device according toclaim 6, comprising an optical sensor.